Effectiveness of elemental diets to prevent oral mucositis associated with cancer therapy: A meta-analysis.

BACKGROUND & AIMS: During chemo- or radiotherapy, oral mucositis is associated with severely affected nutrition, prolonged hospital stays, increased risk of infections, death, hindered cancer treatment, and compromised patient prognosis. Although oral mucositis management is critical, no preventive methods have been firmly established. Nutritional therapy with the oral amino acid-rich elemental diet (ED) Elental® may prevent body composition changes and oral mucositis as dose-limiting toxicities of cancer therapy. This meta-analysis evaluated the effectiveness of ED for the prevention of grade ≥2 oral mucositis in patients with cancer undergoing chemotherapy or radiotherapy. METHODS: A PubMed literature search for randomized clinical trials and/or observational studies in English was conducted. Odds ratios and their confidence intervals were calculated, and fixed- or random-effects models applied. RESULTS: Of 24 relevant studies, nine conducted in Japan (including 445 patients) were subjected to a meta-analysis. Heterogeneity was 56%. Using a random-effects model, the resulting odds ratio (95% confidence interval) was 0.25 (0.10, 0.61). Funnel plot analysis showed no publication bias. There was no heterogeneity by study design, but esophageal cancer exhibited heterogeneity. The respective odds ratios (fixed-effects model) were 0.10 (0.03, 0.30) for observational studies and 0.48 (0.28, 0.82) for randomized control trials. The odds ratio (confidence interval) using a random-effects model was 0.35 (0.12, 0.99) for esophageal cancer; using a fixed-effects model, odds ratios were 0.07 (0.02, 0.29) for gastroenterological cancer and 0.26 (0.04, 1.60) for oral cancers. CONCLUSIONS: The ED reduced the risk of developing oral mucositis, regardless of study design. The effectiveness was more marked in patients with gastroenterological cancer followed by esophageal cancer; ED was not effective in patients with oral cancer.